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JP2008542775A - Device for collection, collection and transfer of biological samples - Google Patents

Device for collection, collection and transfer of biological samples Download PDF

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JP2008542775A
JP2008542775A JP2008515166A JP2008515166A JP2008542775A JP 2008542775 A JP2008542775 A JP 2008542775A JP 2008515166 A JP2008515166 A JP 2008515166A JP 2008515166 A JP2008515166 A JP 2008515166A JP 2008542775 A JP2008542775 A JP 2008542775A
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トリヴァ・ダニエレ
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コパン イノヴェーション リミテッド
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0096—Casings for storing test samples
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    • C12M45/00—Means for pre-treatment of biological substances
    • C12M45/22—Means for packing or storing viable microorganisms

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Abstract

本発明は、液体に対して不浸透性を有し、かつ適切な試料採取手段によって突き破られることが可能な軟質材料から構成される薄膜（１８）からなるキャップ（１２）を具備した試験管（１１）からなることを特徴とする生体試料を採取、収集および移送するための装置（１０）に関する。  The present invention relates to a test tube comprising a cap (12) consisting of a thin film (18) made of a soft material that is impervious to liquids and can be pierced by suitable sampling means. It relates to a device (10) for collecting, collecting and transporting a biological sample, characterized in that it comprises (11).

Description

本発明は、生体試料の採取、収集および移送のための装置に関する。   The present invention relates to a device for collecting, collecting and transferring biological samples.

臨床および診断解析の分野においては、生体試料を採取するための有機材料からなるスワブ（ｓｗａｂｓ）が知られており、それは先端部に分析される試料を吸収するための手段が設けられた円筒状のロッドからなっている。集めた微生物を培養する試験を行うために試料を移送する必要があるなら、試料を保持しているスワブは、分析実験室へ移送される間および分析を待っている間において適切に保存されることが求められるので、それは採取の後すぐに培地を含む殺菌した試験管のなかに入れられる。試験管は、内容物を確実に無菌状態に保つために、キャップによって密封状態にリシール可能（ｒｅ−ｓｅａｌａｂｌｅ）である。このタイプのスワブは、例えば同様の出願である特許文献１または特許文献２に記載されている。   In the field of clinical and diagnostic analysis, swabs made of organic materials for collecting biological samples are known, which are cylindrically shaped with a means for absorbing the sample to be analyzed at the tip. It consists of a rod. If the sample needs to be transported to perform tests to culture the collected microorganisms, the swab holding the sample is properly stored while being transported to the analytical laboratory and waiting for analysis As it is required, it is placed in a sterilized test tube containing medium immediately after collection. The test tube is re-sealable by a cap to ensure the contents remain sterile. This type of swab is described in, for example, Patent Document 1 or Patent Document 2, which are similar applications.

一般的に、このタイプの装置においては、試料を採取する段階と、分析を実施するために試験管を開封する段階とにおいて試料が汚染されるリスクがあり、および注意を払ったとしても、スワブと、例えば非殺菌環境や採取を実行する人または分析をする人の手との間における不意の接触が生じる可能性があることは否定できない。   In general, in this type of equipment, there is a risk of contamination of the sample during the steps of taking the sample and opening the test tube to perform the analysis, and even if care is taken, the swab will For example, it is undeniable that an unexpected contact may occur between the non-sterile environment, the person performing the collection, or the hand of the person performing the analysis.

例えば、特許文献３には、例えば口腔から試料を採取した後に、スワブを試験管のなかに入れ込むことが可能なように、ロッドが壊され、その壊れたロッドの端部を把持するための手段が具備されたキャップによって試験管が密封されるといった、スワブのロッドが破壊可能な装置が記載されている。したがって、分析を実行するときには、試験管は単に開封されるだけでよく、開封者はスワブを触れるリスクなしにキャップだけを取り扱えばよいので、試料と開封者との間の接触の可能性がない。
欧州特許出願公開第０６４３１３１号明細書 国際公開第２００４／０８６９７９号パンフレット 欧州特許出願公開第０３６６８２６号明細書 For example, in Patent Document 3, for example, after taking a sample from the oral cavity, the rod is broken so that the swab can be put into a test tube, and the end of the broken rod is gripped. A device is described in which the rod of the swab can be broken, such that the test tube is sealed by a cap provided with means. Therefore, when performing an analysis, the test tube need only be opened, and the opener only needs to handle the cap without the risk of touching the swab, so there is no possibility of contact between the sample and the opener. .
European Patent Application No. 0643131 International Publication No. 2004/086979 Pamphlet European Patent Application No. 0366826

本発明は、前述のタイプのスワブとは全く異なる、採取された試料の汚染問題を解決する方法を提案する。   The present invention proposes a method for solving the contamination problem of collected samples, which is quite different from the swabs of the type described above.

上記目的を達成するために、本発明は、液体に対して不浸透性を有し、かつ適切な試料採取手段によって穴を開けられることが可能な軟質材料から構成される薄膜からなる、密封閉塞のためのキャップを具備した試験管からなることを特徴とする、生体試料を採取、収集および移送するための装置を提案する。   To achieve the above object, the present invention provides a hermetic closure comprising a thin film made of a soft material that is impermeable to liquid and can be pierced by suitable sampling means. A device for collecting, collecting and transporting a biological sample, characterized in that it comprises a test tube with a cap for the purpose.

本発明は、装置全体と、それを構成する個別の部分、すなわちキャップ、試験管および可能なら前記試料を採取するためのスワブに関する。   The present invention relates to the entire device and the individual parts comprising it, namely a cap, a test tube and possibly a swab for taking said sample.

本発明の特長および利点をより理解する目的で、非限定的な実施形態が、付属の図面を参照しながらこれより記載される。   For a better understanding of the features and advantages of the present invention, non-limiting embodiments will now be described with reference to the accompanying drawings.

図に示されているように、生体試料を採取、収集および移送するための装置１０は、上部にキャップ１２が設けられ、例えば液体状である培地２１を有する試験管１１からなる。   As shown in the figure, a device 10 for collecting, collecting and transporting a biological sample comprises a test tube 11 having a cap 12 at the top and having a culture medium 21 in a liquid state, for example.

その装置は、可能であるなら破壊可能なロッド１５からなるスワブ１３からなり、該スワブは分析される試料を採取するための適切な吸収手段を保持する端部１６を有している。   The device consists of a swab 13 consisting of a rod 15 which can be broken if possible, which swab has an end 16 which holds suitable absorption means for taking the sample to be analyzed.

図１に示されている例において、前記キャップ１２は、ネジ山１４によって試験管の上端にネジ留められることが可能な環状スリーブ１６からなる。キャップによってネジ留められて試験管が閉塞されているときに、試験管のどことも係合していないままになっているキャップの上端部において、前記スリーブの内側には、例えばシリコーンラバーといった軟質材料からなる液体に対して不浸透性を有し、かつ穴を開けられることが可能な円盤状薄膜１８の端部に密封可能なように組み合うのに適した連続または不連続の環状突出部１７が形成されており、組み合わされたスリーブ１６と薄膜１８とで、キャップがネジ留められたときにおける試験管１１の密封閉塞手段を構成している。   In the example shown in FIG. 1, the cap 12 comprises an annular sleeve 16 that can be screwed to the upper end of the test tube by means of a thread 14. At the top of the cap that remains unengaged with the test tube when it is screwed by the cap and closed, the inside of the sleeve has a soft material such as silicone rubber. A continuous or discontinuous annular protrusion 17 suitable for sealingly fitting at the end of a disc-shaped membrane 18 that is impervious to liquids that can be perforated The sleeve 16 and the thin film 18 formed and combined constitute a sealing and closing means for the test tube 11 when the cap is screwed.

前記薄膜１８は、好ましくは、図に示されているように、実質的にＵ字またはＶ字型の断面となるような凹形状を有している。   The thin film 18 preferably has a concave shape that has a substantially U-shaped or V-shaped cross section, as shown in the figure.

また、その薄膜は上部をプラスチック材料または他の適切な材料、例えばアルミニウムよりなるフィルム１９によって保護され、該フィルムはスリーブ１６の上端に適用されており、それはキャップを確実に密封する機能を有する。   The thin film is also protected at the top by a film 19 made of plastic material or other suitable material, such as aluminum, which is applied to the upper end of the sleeve 16, which serves to securely seal the cap.

図２に部分的に示されている本発明の別様態においては、例えばシリコーンラバーといった軟質材料からなる液体に対して不浸透性を有し、かつ穴を開けられることが可能な薄膜１８は、例えばフロック加工によって堆積した液体吸収性材料の層２２によって上部を覆われている。   In another embodiment of the present invention, partially shown in FIG. 2, the thin film 18 that is impervious to liquids made of a soft material, such as silicone rubber, and that can be perforated, For example, the upper part is covered with a layer 22 of liquid absorbent material deposited by flocking.

例示されている装置の操作は以下のようになされる。まず、スワブ１３手段によって検体から試料を採取し、その後に試験管１１からキャップ１２がはずされ、採取された試料を保持している端部１６が培地２１に入るようにスワブ１３が挿入される。もしスワブが上記のことを実行することができるほど十分に長いのであれば、破壊可能なロッド１５が最初に壊されることによって、スワブを有する試験管はキャップ１２をしめ直すことで簡単にリシールされる。   The illustrated apparatus is operated as follows. First, a sample is collected from the specimen by the swab 13 means, and then the cap 12 is removed from the test tube 11, and the swab 13 is inserted so that the end 16 holding the collected sample enters the culture medium 21. . If the swab is long enough to carry out the above, the breakable rod 15 is broken first, so that the test tube with the swab can be easily resealed by re-tightening the cap 12. The

薄膜１８が凹形状をしているために、スワブのロッドは、試験管のなかに斜めに入れられ、図１に示されているように実質的に斜めの位置に留まり続けるので、試験管の長手方向の軸に沿って展開している空間２０は試験管内において自由な空間となっている。   Because of the concave shape of the membrane 18, the swab rod is placed diagonally in the test tube and remains in a substantially diagonal position as shown in FIG. The space 20 developed along the longitudinal axis is a free space in the test tube.

図１の配置で装置１０は保たれ、分析のために移送される。分析するために、作業者は、薄膜１８の中央部に対してマイクロピペットの端部を押し当て、該薄膜に圧力をかけて穴を開けることでマイクロピペットを挿入する。それから、ピペットは、分析される試料を有する培地２１に到達するまで、空間２０に沿って試験管１１のなかを進む。次に、試料を有する培地から望ましい量の試料を取ったピペットは、分析を実行するために試験管から離されるのであるが、前記過程ではピペットのみが試料と接触するので該試料は汚染から免れることが可能である。   In the arrangement of FIG. 1, the device 10 is kept and transported for analysis. In order to analyze, the operator inserts the micropipette by pressing the end of the micropipette against the center of the thin film 18 and making a hole by applying pressure to the thin film. The pipette then advances through the test tube 11 along the space 20 until it reaches the medium 21 with the sample to be analyzed. Next, the pipette that took the desired amount of sample from the medium with the sample is removed from the test tube to perform the analysis, but only the pipette contacts the sample in the process, so the sample is free from contamination. It is possible.

また、図２に示されている本発明の別様態においては、試験管からマイクロピペットが取り除かれるときに、前記吸収性材料２２の層が、薄膜１８の貫通開口部を該ピペットが通過する際に摩擦のために流出する可能性がある液体、特には水滴状の液体を吸収することが可能である。これによって、試料の制御不可能な流出およびそれに続く汚染を避けることができるという利点が完全に達成される。   Also, in another embodiment of the invention shown in FIG. 2, when the micropipette is removed from the test tube, the layer of absorbent material 22 passes through the through-opening of the thin film 18 as it passes. It is possible to absorb liquids that can flow out due to friction, especially water droplets. This completely achieves the advantage that uncontrollable spillage of the sample and subsequent contamination can be avoided.

前述したことから理解されるように、本発明は、特定の実施形態とは関係なく、初期状態にある物体を効果的に獲得することが可能である。   As can be understood from the foregoing, the present invention can effectively acquire an object in an initial state regardless of a specific embodiment.

本発明では、前述の例に対して構造に関する修正を施した無数の形態をとることが可能であり、例えば、試験管やキャップの材料や形状、およびそれらの構成要素を変更することができる。加えて、スワブのロッドの寸法、および試験管内におけるその配置を、図に示されている状態とは異なる形態とすることが可能であり、そのときでも試験管の長手方向の軸に沿って存在する試験管の内部空間は自由なままにされており、その空間においてピペットで分析される試料を採取するための動作を実行することができる。培地は、例えばピペットまたは他の適切な手段で採取されることが可能な低粘度のゲルといった、液体以外の形態を有している。   In the present invention, it is possible to take innumerable forms obtained by modifying the above-described examples with respect to the structure. For example, the materials and shapes of test tubes and caps, and the components thereof can be changed. In addition, the dimensions of the swab rod and its placement in the test tube can be configured differently from the situation shown in the figure, but still exist along the longitudinal axis of the test tube The interior space of the test tube is left free, and an operation can be performed to collect a sample to be analyzed with a pipette in that space. The medium has a form other than a liquid, such as a low viscosity gel that can be collected by pipette or other suitable means.

本発明の装置の長手方向断面図である。1 is a longitudinal sectional view of a device of the present invention. 本発明の装置の別様態における細部、すなわち前記キャップの長手方向断面図である。FIG. 4 is a detail in another aspect of the device of the present invention, i.e. a longitudinal sectional view of the cap.

符号の説明Explanation of symbols

１０ 装置
１１ 試験管
１２ キャップ
１３ スワブ
１４ ネジ山
１５ ロッド
１６ 環状スリーブ
１７ 環状突出部
１８ 円盤状薄膜
１９ 保護フィルム
２０ 空間
２１ 培地
２２ 液体吸収性材料の層 DESCRIPTION OF SYMBOLS 10 Apparatus 11 Test tube 12 Cap 13 Swab 14 Thread 15 Rod 16 Annular sleeve 17 Annular protrusion 18 Disc-shaped thin film 19 Protective film 20 Space 21 Medium 22 Layer of liquid absorbent material

Claims (12)

生体試料を採取、収集および移送するための装置（１０）であって、
液体に対して不浸透性を有し、かつ適切な試料採取手段によって突き破られることが可能な軟質材料から構成される薄膜（１８）からなるキャップ（１２）を具備した試験管（１１）からなることを特徴とする生体試料を採取、収集および移送するための装置。 An apparatus (10) for collecting, collecting and transporting biological samples,
From a test tube (11) with a cap (12) consisting of a thin film (18) made of a soft material that is impervious to liquid and can be breached by suitable sampling means A device for collecting, collecting and transporting biological samples characterized in that. 前記キャップ（１２）は、環状スリーブ（１６）からなっており、閉塞位置にあるとき試験管と係合していない該スリーブの上端部には、前記薄膜（１８）と密封可能なように組み合うのに適した手段（１７）が設けられていることを特徴とする請求項１に記載の装置。   The cap (12) is composed of an annular sleeve (16), and the upper end of the sleeve that is not engaged with the test tube when in the closed position is assembled so as to be able to seal with the thin film (18). 2. Device according to claim 1, characterized in that means (17) suitable for the following are provided. 前記手段（１７）は、円盤状の薄膜（１８）の端部に密封可能なように組み合うのに適した連続または不連続の環状突起部からなることを特徴とする請求項２に記載の装置。   3. Device according to claim 2, characterized in that said means (17) comprise continuous or discontinuous annular projections suitable for sealingly fitting at the end of a disc-shaped membrane (18). . 前記環状スリーブ（１６）は、ネジ山（１４）によって前記試験管の上端部にネジ留められることを特徴とする請求項２に記載の装置。   3. A device according to claim 2, characterized in that the annular sleeve (16) is screwed to the upper end of the test tube by means of a screw thread (14). 前記薄膜（１８）は、凹形状をなしていることを特徴とする請求項１に記載の装置。   The device according to claim 1, wherein the thin film has a concave shape. 前記薄膜（１８）は、シリコーンラバーからなることを特徴とする請求項１に記載の装置。   2. A device according to claim 1, characterized in that the thin film (18) is made of silicone rubber. 前記薄膜（１８）は、液体吸収性材料の層（２２）で上部が覆われていることを特徴とする請求項１に記載の装置。   The device according to claim 1, characterized in that the thin film (18) is covered at the top with a layer (22) of liquid absorbent material. 前記薄膜（１８）は、フロック加工によって堆積した液体吸収性材料の層（２２）で上部が覆われていることを特徴とする請求項７に記載の装置。   8. Device according to claim 7, characterized in that the thin film (18) is covered at the top with a layer (22) of liquid absorbent material deposited by flocking. 前記薄膜は、キャップ（１２）の上端部に適用される保護フィルム（１９）によって上を覆われていることを特徴とする請求項１に記載の装置。   The device according to claim 1, characterized in that the thin film is covered with a protective film (19) applied to the upper end of the cap (12). キャップ（１２）と、検体から試料を採取するためのスワブ（１３）とを具備する試験管（１１）からなることを特徴とする請求項１に記載の装置。   Device according to claim 1, characterized in that it comprises a test tube (11) comprising a cap (12) and a swab (13) for collecting a sample from a specimen. 請求項１に記載の装置のためのキャップ（１２）。   A cap (12) for a device according to claim 1. 実質的に前述され、および付属の図面において示されている装置およびキャップ。   Apparatus and cap substantially as hereinbefore described and shown in the accompanying drawings.
JP2008515166A 2005-06-08 2006-05-02 Device for collection, collection and transfer of biological samples Pending JP2008542775A (en)

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IT001057A ITMI20051057A1 (en) 2005-06-08 2005-06-08 DEVELOPMENT, COLLECTION AND TRANSPORT OF BIOLOGICAL SAMPLES
PCT/EP2006/061975 WO2006131424A1 (en) 2005-06-08 2006-05-02 Device for the withdrawal, collection and transport of biological specimens

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JP2008542775A true JP2008542775A (en) 2008-11-27

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CN101171330B (en) 2012-04-25
AU2006256883A1 (en) 2006-12-14
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ES2332237T3 (en) 2010-01-29
CN101171330A (en) 2008-04-30
US20090048534A1 (en) 2009-02-19
EP1893740A1 (en) 2008-03-05
WO2006131424A1 (en) 2006-12-14
ATE426658T1 (en) 2009-04-15
DE602006005927D1 (en) 2009-05-07
CA2611289A1 (en) 2006-12-14
ITMI20051057A1 (en) 2006-12-09
EP1893740B1 (en) 2009-03-25

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